100+
Installed around the world
KARL100
Automatic radiopharmaceuticals dispensing and infusion system for PET and SPECT
- Infertility and Radiation Protection
- Multiple Simultaneous Infusions
- Compatibility and Automatic Opening of Lead Pots
KARL100 is a mobile unit designed to manage automatically both syringe dispensing and infusion of FDG (and other PET Radiopharmaceuticals) requiring neither civil works nor dedicated clean rooms.
Used in the following contexts:
In-house
Designed and Manufactured by Tema Sinergie
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Features
Thanks to its unique features, KARL100 is a valuable assistant for all PET imaging centers that need to improve the departmental workflow by making it faster, safer, and more efficient for both operators and patients.
Features
Area for loading the lead pot
A lead pot housing system designed to provide high operational flexibility and protection for the operator when handling radiopharmaceuticals.
It allows for the use of shielded containers and lead pots of different brands, models, and sizes, enabling the radiopharmacy to maintain its standard procedures without needing to use specialized components.
Features
Lead Pot Opening System
Automatic lead pot opening system: reduces the need for manual intervention precisely during the phase when radioactivity is at its highest.
The system helps simplify the workflow, limit the risk of exposure, and ensure safer and more efficient handling of the radiopharmaceutical.
Features
Outer Cover
The top cover, made of high-density (HD) polyurethane, ensures sturdiness and compactness and protects the operator from accidental contact during work operations.
Features
Label Printer Area
The DYMO LabelWriter 450 Turbo is the standard printer for the KARl100 2.0 System and is installed beneath the touchscreen PC. With a print speed of up to 55 labels per minute, it is one of the fastest printers in its class and also ensures high-quality label printing.
The printer’s flexibility, combined with the KARl100 2.0 System software, allows for the configuration of various label parameters, including the selection of information to be printed and the inclusion of a barcode.
Features
Screened Area
- MOTHER VIAL
The Mother Vial is the main container that holds the radiopharmaceutical in bulk form, from which individual doses are drawn for administration to patients. In the KARL100 2.0 system, the Mother Vial is housed in a shielded compartment that ensures radiation protection for the operator and is managed through a fully automated, sterile, and safe process. The system precisely dispenses the required amount of radiopharmaceutical for each dose, preventing waste and ensuring that the patient is never directly connected to the Mother Vial, thereby eliminating the risk of cross-contamination.
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DOSE CALIBRATOR
The dose calibrator is installed inside the central mobile unit. It is a third-party Class IIb medical device in accordance with Directive 93/42/EEC, Annex II (excluding point 4). It consists of a Special Mini measurement chamber designed to measure radioactive activity.
Features
Touchscreen PC
Touch Panel PC: user interface for machine control, monitoring, and configuration.
Features
Drilling area of the bulk bottle.
The needle insertion device is installed at the top of the machine's work area. A special housing holds the 0.22 μm filter and the needle in place, ensuring that the vials are punctured correctly.
Features
Filling Area
The filling area is equipped with a ventilation system that uses an H14 HEPA filter to ensure Grade A air quality in critical areas. In fact, the KARl100 2.0 system is the only dose-dispensing system on the market capable of filling syringes in a GMP Class A (ISO 5) environment.
Workflow
A SIMPLE AND SECURE WORKFLOW
A new concept for the dispensing
and infusion of PET radiopharmaceuticals
Only 5 simple steps from the loading to the first injection of the radiopharmaceutical
Step 01
Installing the multidose kit
Each consumable kit comes in a sterile packaging, and covers the dispensing processes for the whole working day.
It’s extremely easy to install, as each component fits only into a specific slot; such operation will take no longer than two minutes.
Step 02
Testing the kit and the system
The system will automatically perform a warm up test to check for the proper installation and tightness of the consumable kit and make sure the pumps, bubble point, pressure sensors and peristaltic pump are working correctly.
The whole process is designed to avoid wasting both saline solution and radiopharmaceuticals, ensuring the highest safety level to the operator at the same time.
Step 03
Loading the lead pot
Once the multidose (bulk) vial info are inserted (total activity, calibration time and total volume), the closed transport lead pot can be positioned in its housing.
The system then automatically opens the lead pot and transfers the whole volume. An acoustic alarm will go off as soon as the process is complete.
Step 04
Syringe preparation
Preparation of the syringe begins with entering patient information into the system. This can be done manually or by downloading the patients list via DICOM.
Once dispensing has started, the whole dispensing procedure is automatic and ends with the printing of the label with patient information to be applied to the syringe.
Step 05
Injecting the radiopharmaceutical
The Rad-Inject, or shielded syringe, is positioned onto the stand and connected to the patient, then the infusion process starts.
During the infusion, the operator can already start programming a new dispensing cycle on the same Karl100: a groundbreaking feature for dispensing and infusion processes for PET radiopharmaceuticals which allows to treat more patients, while enhancing time management.
Perfect Partners
Making KARL100 the most complete and safest Class A
multidose administration system available worldwide.
RAD-INJECT
The smallest automatic injector for radiopharmaceuticals.
It’s the answer for operator radioprotection, mainly during radiopharmaceutical handling and injection phase.
STAND
Rad-Inject is equipped with a rolling stand with additional shielding to offer maximum safety for the operator, also in this phase.
More than 250 units installed worldwide
185 Units installed in 22 Countries:
Austria (3), Belarus (2), Belgium (3), Bulgaria (2), Czechia (6), Denmark (8), Estonia (2), Finland (12), France (19), Germany (9), Greece (2), Hungary (4), Italy (55), Latvia (1), Netherlands (16), Poland (2), Romania (10), Slovenia (1), Spain (6), Sweden (4), Switzerland (9), UK (9)
32 Units installed in 12 Countries:
Bahrain (1), China (1), Iraq (3), Israel (1), Jordan (1), Mongolia (1), Qatar (1), Saudi Arabia (14), Sri Lanka (1), Thailand (2), Turkiye (1), United Arab Emirates (5)
4 Units installed in 2 Country:
Algeria (3), South Africa (1)
7 Units installed in 4 Countries:
Chile (2), Costa Rica (1), Ecuador (2), United States of America (2)
23 Units installed in 2 Countries:
Australia (20), New Zealand (3)
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